Recall Z-1434-2021 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surg
| Date | Apr 19, 2021 (initiated Mar 4, 2021) |
| Status | Terminated |
| Reason | Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions |
| Root cause | Software design |
| Action | Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and con |
| Quantity | 99 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |